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Active ingredient: Everolimus
Marketing authorisation holder: Novartis Europharm Ltd
Availability: Private Sector
Variations: During clinical trials and post-marketing surveillance of everolimus, cases of renal failure including acute renal failure and pulmonary embolism with fatal outcome were reported. Hence it was recommended to monitor renal function and urinary protein before and during treatment. After reviewing the pharmacokinetic data, CHMP did not approve the introduction of dose adjustments for everolimus in patients who had renal failure.
The SmPC was updated for the inclusion of pulmonary embolism, proteinuria, renal failure as well as acute renal failure as undesirable effects. The former is classified as uncommon whilst the latter three may occur commonly.
Reference: European Medicines Agency. Afinitor. [online]. 2011July 1 [cited 2011 Aug 23]; Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001038/human_med_000633.jsp&murl=menus/medicine s/medicines.jsp&mid=WC0b01ac058001d124